U.S. patent number 11,141,566 [Application Number 15/344,524] was granted by the patent office on 2021-10-12 for steering tool.
This patent grant is currently assigned to Bendit Technologies Ltd.. The grantee listed for this patent is Bendit Technologies Ltd.. Invention is credited to Oz Cabiri.
United States Patent |
11,141,566 |
Cabiri |
October 12, 2021 |
Steering tool
Abstract
A steering tool includes an internal tube disposed inside an
external tube. The internal and external tubes are arranged for
longitudinal axial movement relative to one another. A distal
portion of the internal tube is fixedly joined to a distal portion
of the external tube. At least one of the tubes may include, over
at least some of its length, two continuous, longitudinal zones of
solid material separated from each other by a longitudinal gap. At
least one of the tubes may include a flexible distal portion distal
to the joining zone, the flexible distal portion being more
flexible than other portions of that tube.
Inventors: |
Cabiri; Oz (Hod HaSharon,
IL) |
Applicant: |
Name |
City |
State |
Country |
Type |
Bendit Technologies Ltd. |
Petach Tikva |
N/A |
IL |
|
|
Assignee: |
Bendit Technologies Ltd.
(Petach Tikva, IL)
|
Family
ID: |
1000005860572 |
Appl.
No.: |
15/344,524 |
Filed: |
November 6, 2016 |
Prior Publication Data
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|
|
Document
Identifier |
Publication Date |
|
US 20180126122 A1 |
May 10, 2018 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
25/0043 (20130101); A61M 25/0138 (20130101); A61B
1/0057 (20130101); A61B 1/0055 (20130101); A61M
25/0113 (20130101); A61B 17/1214 (20130101); A61M
2025/0175 (20130101); A61B 2017/1205 (20130101); A61M
25/0147 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61B 1/005 (20060101); A61B
17/12 (20060101); A61M 25/00 (20060101) |
Field of
Search: |
;600/585 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2006/012668 |
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Feb 2006 |
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WO |
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2015/095475 |
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Jun 2015 |
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WO |
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2016/160694 |
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Oct 2016 |
|
WO |
|
Other References
PCT Search and Written Opinion PCT/IB2017/056913, dated May 2,
2018. cited by applicant.
|
Primary Examiner: Cerioni; Daniel L
Attorney, Agent or Firm: Dekel Patent Ltd. Klein; David
Claims
What is claimed is:
1. A steering tool comprising: an internal tube disposed inside an
external tube, said internal and external tubes being arranged for
longitudinal axial movement relative to one another, wherein a
distal portion of said internal tube is fixedly joined to a distal
portion of said external tube at a joining zone, and said internal
tube is not fixedly joined to said external tube at any point
distal to said joining zone, and at least one of said internal and
external tubes is formed with transverse slots near a distal end
thereof, and wherein the longitudinal axial movement causes bending
of the distal ends of said tubes; wherein at least one of said
tubes comprises, over at least some length of said at least one of
said tubes, two continuous, longitudinal zones of solid material
separated from each other by a longitudinal gap; and wherein at
least one of said tubes comprises a flexible distal portion which
is entirely distal to said joining zone, and wherein said
longitudinal gap comprises a separation line that extends into said
flexible distal portion.
2. The steering tool according to claim 1, wherein said flexible
distal portion is more flexible than other portions of that
tube.
3. The steering tool according to claim 1, wherein said flexible
distal portion is formed with helical grooves and said separation
line extends into one of said helical grooves.
4. The steering tool according to claim 1, further comprising a
covering over said flexible distal portion.
5. The steering tool according to claim 4, wherein said covering
comprises a transmitter or receiver.
6. The steering tool according to claim 1, wherein at least one of
said tubes comprises a most proximal portion, a middle portion and
a most distal portion, wherein the most distal portion is more
flexible than the middle and the most proximal portions, and the
most proximal portion is more axially stiff than the middle and the
most distal portions.
7. The steering tool according to claim 1, wherein said gap
comprises apertures axially separated from each other
longitudinally along said separation line.
8. The steering tool according to claim 3, wherein said helical
grooves extend to proximal and distal end faces of said flexible
distal portion such that each of the proximal and distal end faces
of said flexible distal portion has a circumferential opening.
9. The steering tool according to claim 1, wherein said internal
and external tubes are each formed with one or more alignment holes
for correct axial and rotational alignment of said internal and
external tubes during joining and assembly.
Description
FIELD OF THE INVENTION
The present invention generally relates to a steering tool for
steering medical devices through body lumens.
BACKGROUND OF THE INVENTION
PCT Patent Application PCT/US2013/040691, to the present inventor,
describes a steering tool for steering medical devices through body
lumens. The steering tool has an internal tube disposed inside an
external tube. The internal and external tubes are arranged for
longitudinal axial movement relative to one another. The distal end
of the internal tube is fixedly joined to the distal end of the
external tube. One or both of the internal and external tubes is
slotted near the distal end thereof. The longitudinal axial
movement causes bending of the distal ends of the tubes. One or
both of the internal and external tubes are slotted near the distal
ends thereof. The steering tool provides a distal tip which
combines steerability, flexibility and torqueability. The tool
eliminates the need for pull/push wires.
Some of the advantages of that steering tool include reduced cross
section, circular cross section in each direction for uniform
stability of bending in different directions (towards two or more
sides), very thin wall thickness, and applicability to very small
tubes (e.g., diameters of 0.2-3 mm). The steering tool also works
well with larger tubes. The steering tool simplifies production and
reduces the number of parts for any steerable tool in medical and
industrial fields.
SUMMARY OF THE INVENTION
The present invention seeks to provide further improvements to the
steering tool for steering medical devices through body lumens, as
is described more in detail hereinbelow.
There is thus provided in accordance with an embodiment of the
present invention a steering tool including an internal tube
disposed inside an external tube, the internal and external tubes
being arranged for longitudinal axial movement relative to one
another, wherein a distal portion of the internal tube is fixedly
joined to a distal portion of the external tube at a joining zone,
and at least one of the internal and external tubes is formed with
transverse slots near the distal end thereof, and wherein the
longitudinal axial movement causes bending of the distal ends of
the tubes, and wherein at least one of the tubes includes, over at
least some of its length, two continuous, longitudinal zones of
solid material separated from each other by a longitudinal gap.
In accordance with an embodiment of the present invention at least
one of the tubes includes a flexible distal portion distal to the
joining zone, the flexible distal portion being more flexible than
other portions of that tube. The flexible distal portion may be
formed with helical grooves.
In accordance with an embodiment of the present invention a
covering is provided over the flexible distal portion. The covering
may or may not be softer than the flexible distal portion.
In accordance with an embodiment of the present invention the
covering includes a transmitter or receiver.
In accordance with an embodiment of the present invention at least
one of the tubes includes a most proximal portion, a middle portion
and a most distal portion, wherein the most distal portion is more
flexible than the middle and the most proximal portions, and the
most proximal portion is more axially stiff than the middle and the
most distal portions.
In accordance with an embodiment of the present invention the gap
includes a separation line plus apertures formed through the gap,
axially separated from each other longitudinally along the gap. The
apertures may be stadium (rectangle with round ends) shaped, for
example.
In accordance with an embodiment of the present invention the
internal and external tubes are each formed with one or more
alignment holes for correct axial and rotational alignment of the
internal and external tubes during joining and assembly.
There is also provided in accordance with an embodiment of the
present invention a steering tool including an internal tube
disposed inside an external tube, the internal and external tubes
being arranged for longitudinal axial movement relative to one
another, wherein a distal portion of the internal tube is fixedly
joined to a distal portion of the external tube at a joining zone,
and at least one of the internal and external tubes is formed with
transverse slots near the distal end thereof, and wherein the
longitudinal axial movement causes bending of the distal ends of
the tubes, and wherein at least one of the tubes includes a
flexible distal portion distal to the joining zone, the flexible
distal portion being more flexible than other portions of that
tube.
In accordance with a method of the present invention, the steering
tool may be used to push, pull or guide a camera, an electrical
energy device, an illumination device, a thrombectomy device, a
fiber optic device or a laser device to a treatment site.
The steering tool has many applications in the delivery of tools or
substances through body lumens. One exemplary application is that
of endovascular coiling to treat cerebral aneurysms. In the prior
art, a coil is delivered to the aneurysm in an effort to promote
blood clotting around the coils, so as to seal the aneurysm and/or
reduce pressure on the blood vessel wall. In the prior art, the
coil is delivered from the distal end of a microcatheter. Many
aneurysms require delivering more than one coil in order to achieve
high packing density. There are several challenges in delivering
more than one coil. For example, in order to engage the aneurysm,
it is difficult to correctly aim and position the tip of the coil
delivery tool inside the aneurysm. Another example is the
difficulty to maintain the tip of the delivery tool stable while
injecting the coil into the aneurysm, and at the same time, avoid a
kick back effect of the tip. Yet another example is the difficulty
to re-position the tip inside the aneurysm to deliver another coil
in the remaining open space without retracting the delivery tool.
In the prior art, the delivery tool (catheter) must be retracted,
then re-entered at a different catheter angle. In contrast to the
prior art, in the steering tool of the present invention, the
steering tool does not have to be retracted, but rather stays in
place and the operator simply rotates the tip to correctly aim the
tip, and the tip remains stable.
As another example, in the prior art, it is difficult to guide a
catheter from the aortic arch to the common carotid arteries, and
from there to the carotid arterial branches to the brain. This can
be especially difficult with patients in which the aortic arch is
blocked, such as with calcifications, or is weak and deformed, such
as in older patients. In contrast, the steering tool of the present
invention is steerable through lumens with many bends and maintains
a good level of torque and pushability throughout the bends, so
that the steering tool can negotiate the required bends from the
aortic arch to the common carotid arteries and the carotid arterial
branches, even in the presence of calcifications.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully
from the following detailed description taken in conjunction with
the drawings in which:
FIG. 1 is a simplified illustration of a distal portion of a
steering tool, in accordance with a non-limiting embodiment of the
present invention;
FIG. 2 is a simplified illustration of the steering tool, in
accordance with a non-limiting embodiment of the present invention,
showing the distal portion of one of the tubes (e.g., the internal
tube);
FIG. 3 is another simplified illustration of the distal portion of
FIG. 3, showing that the tube includes two continuous, longitudinal
zones of solid material separated from each other by a longitudinal
gap;
FIG. 4 is a simplified illustration of a proximal portion of the
steering tool; and
FIG. 5 is a simplified pictorial illustration of the steering tool,
showing the most distal portion, middle portion and most proximal
portion of the tool.
DETAILED DESCRIPTION OF EMBODIMENTS
Reference is now made to FIG. 1, which illustrates a steering tool
10, in accordance with a non-limiting embodiment of the present
invention.
Steering tool 10 includes an internal tube 12 disposed inside an
external tube 14. A distal portion of internal tube 12 is fixedly
joined to a distal portion of external tube 14 at a joining zone 16
("joining" is defined below). The joining zone, for any of the
embodiments, may be distanced from the distal tip of the tubes or
may be at the distal tip of the tubes. The internal and external
tubes 12 and 14 are arranged for longitudinal axial movement
relative to one another (except for their distal portions which are
joined together), which causes bending of the distal ends of the
tubes 12 and 14. One or both of the internal and external tubes 12
and 14 may be formed with transverse slots 18 near the distal end
thereof. In the illustrated embodiment of FIG. 1, both of the
internal and external tubes 12 and 14 is formed with transverse
slots 18.
Internal and external tubes 12 and 14 may be made of any suitably
flexible, medically safe material, such as but not limited to,
stainless steel (e.g., AISI 316), nitinol, cobalt-chromium alloy,
nickel-titanium alloy, and others, glass fibers, plastics (e.g.,
nylon, polypropylene, and many others) or combinations thereof.
The term "joining" encompasses any method for attaching the
materials of the tubes together, such as but not limited to,
welding, ultrasonic welding, thermal bonding, adhesive bonding,
molding, and others. For example, joining zone 16 may be an
alignment hole formed in one or both of the tubes for helping to
register the tubes in proper angular and axial orientation with
each other during the joining process. An alignment pin (not shown)
may be inserted in the alignment holes to hold the tubes in the
proper alignment during joining. The alignment holes may be
off-center and/or of two different diameters to ensure that the
tubes are not accidentally aligned incorrectly.
As is now explained, a distal portion of one of the tubes may be
flexible and expandable. This may be advantageous in the joining
process--the flexible and expandable portion can expand during
joining (especially helpful for welding or other types of thermal
joining) which can compensate for expansion of the tube material
due to heating or compensate for the difference in diameter at the
joining point, and thus reduce the need to add material that may
clog the working channel.
One or both of the internal and external tubes 12 and 14 (in the
illustrated embodiment of FIG. 1, it is the internal tube 12) may
include a flexible distal portion 20 distal to the joining zone 16.
The flexible distal portion 20 is more flexible than other portions
of that tube (in the illustrated embodiment, tube 12).
One way of making the distal portion 20 to be flexible is by
forming it with helical grooves 22 (seen best in FIGS. 2 and 3).
The helical grooves 22 increase the springiness of distal portion
20 and permit distal portion 20 to expand or contract radially
during the joining process.
A covering 24 (shown in FIG. 1) may be optionally placed over
flexible distal portion 20. Covering 24 may be made of an
elastomeric material, such as but not limited to, silicone, rubber,
neoprene, latex and others. Covering 24 may be softer than flexible
distal portion 20. Covering 24 may include a transmitter or
receiver 26, which may be used to transmit positional data of the
steering tool tube assembly when negotiating a body lumen. Covering
24 may be kept on the steering tool tube assembly or may be
optionally removed before or during use.
Reference is now made to FIG. 3. One or both of the internal and
external tubes 12 and 14 (in the illustrated embodiment of FIG. 1,
it is the internal tube 12) may include, over at least some of its
length, two continuous, longitudinal zones 26 and 28 of solid
material separated from each other by a longitudinal gap. The gap
may be just apertures 32 spaced axially from each other along a
portion of the length of the tube. Alternatively, the gap may
include a separation line 30 plus apertures 32 axially separated
from each other longitudinally along the separation line 30. The
apertures 32 may have a stadium shape (that is, rectangular with
round ends). Alternatively, apertures 32 may have other shapes,
such as but not limited to, oval, circular, elliptical, polygonal,
irregular and others. As another alternative, the gap may be just
the separation line 30.
Accordingly, in one aspect of the invention, instead of joining two
full tubes (one inner and the other outer) to each other at the
ends of the tubes to make the steering device, one of the tubes
(preferably, but not necessarily, the inner tube), is not a full
360.degree. perimeter tube, but rather a flexible member formed
with a gap. As opposed to the prior art, in which distal ends of
two tubes are joined to each other, in this embodiment there is
only one tube (the external tube) and there is no inner tube.
Instead of the inner tube, a metal strip is bent or rolled or
otherwise formed into a curved (e.g., cylindrical) shape, having
curved sides separated from each other by a gap (e.g., about 1-1000
microns wide, or more preferably 20-500 microns).
The two continuous, longitudinal zones 26 and 28 of solid material
help increase the bending stiffness of the steering tool, yet at
the same time, due to the gap, have better resistance to crack or
stress failure. The apertures 32 may provide stress relief to
increase the resistance to crack or stress failure. This provides
risk management, such that in case of a break, the crack does not
continue to the second solid line.
Reference is now made to FIG. 5. In the steering tool 10, one or
both of the tubes 12 and 14 includes a most proximal portion 34, a
middle portion 36 and a most distal portion 38. In accordance with
a non-limiting embodiment of the present invention, the most distal
portion 38 is more flexible than the middle portion 36 and the most
proximal portion 34. In accordance with a non-limiting embodiment
of the present invention, the most proximal portion 34 is more
axially stiff than the middle portion 36 and the most distal
portion 38. The two continuous, longitudinal zones of solid
material (FIG. 3) may be present in the middle portion 36 and may
also be present in the most proximal portion 34. They may also be
present in the most distal portion 38.
The middle portion 36 may be flexible for steering through body
lumens, whereas the most proximal portion 34 is more axially stiff
because it is the portion that connects to a manipulation handle
(not shown). The manipulation handle may be as described in PCT
Patent Application PCT/US2014/071075 or U.S. patent application
Ser. No. 15/057,329.
Reference is now made to FIG. 4, which illustrates the proximal
portion 34 of the steering tool. The proximal portion 34 may
include continuously connected links, which alternate in shape
between U-shapes and inverted (upside down) U-shapes. The sides of
the U-shapes and inverted U-shapes are not straight, but instead
are laterally tilted inwards or outwards. This shape provides good
axial rigidity for bearing high axial loads and spreads the load
over a plurality of the links, thereby reducing the chance of
breaking. The shape is designed not to generate torque (which could
happen with spring or diagonal shapes) that would affect the
bending mode.
The steering tool can be used to deliver fluids to places in a body
with high accuracy, such as but not limited to, direct injection of
drugs into the brain. For example, the tool may be used as a needle
to protrude through or into a blood vessel and inject substances
directly into the brain, tumor or infected area. The steering tool
may be used as a catheter to direct and deliver cooled gas to
freeze tumors or other areas. The steering tool may be used as a
catheter to guide fiber optic or laser devices for illumination,
treatment, ablation or drying or other uses.
In any of the embodiments, the distal edge shape of the internal
member/tube, external tube and/or overall tool may be not only
circular, but also shaped as an electrode, needle or other
shapes.
In any of the embodiments, either one or both of the internal
member/tube and the external tube may have a portion proximal to
the joining zone which is pre-shaped and made of a shape memory
material (e.g., nitinol) (such as, without limitation, portion 36
of FIG. 5). The combination of the steerable tip and the
pre-shaped, shape memory portion may add further possibilities of
the steering tool negotiating differently shaped body lumens. The
pre-shaped, shape memory portion may be initially in a somewhat
straight or contracted configuration inside a guiding or introducer
catheter before deployment out of the catheter, and then revert to
its pre-shaped configuration after deployment out of the catheter.
Similarly, the pre-shape can be achieved by locally heat-treating
the tool at the portion which it is desired to have the
pre-shape.
* * * * *